WASHINGTON (Reuters) - Bausch & Lomb has stopped shipping its ReNu brand contact lens solution after a number of people using the product reported getting a serious eye infection, the U.S. Food and Drug Administration said on Monday.

The FDA said that 109 cases of the rare but serious infection that may cause loss of vision had been reported to the Centers for Disease Control and Prevention (CDC) from 17 U.S. states. But the agency said during a conference call that it was not aware of a link between the infection and specific products.

Consumers Are Advised to Follow Good Hygiene Practices and Manufacturers? Instructions to Prevent Infection

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are alerting health care professionals and their patients who wear soft contact lenses to an increasing number of reports in the United States of rare but serious fungal infections in the eye that can cause permanent loss of sight. Some patients have reported a significant loss of vision, resulting in the need for a corneal transplant.

A fungus called Fusarium has been identified as the cause of the reported infections. As of April 9, 2006, 109 cases of suspected Fusarium keratitis are under investigation by CDC and public health authorities in 17 states of the U.S.

"This is a serious infection and soft contact lens users should be mindful of the potential to develop this problem," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "We're advising consumers to practice good basic hygiene and follow manufacturers' instructions for proper use, cleaning and storage of their lenses, and report any signs of infection to their doctors."

Clinicians who evaluate patients with microbial keratitis should consider that a fungal infection may be involved and refer the patient to an ophthalmologist, if appropriate to obtain a specimen for laboratory analysis. In addition, the FDA and CDC are urgently advising consumers to take precautions to prevent contamination of the soft lenses and the products used to maintain them. These preventive practices for contact lens wearers include the following:

Wash hands with soap and water, and dry (lint-free method) before handling lenses.
Wear and replace lenses according to the schedule prescribed by the doctor.
Follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer.
Keep the contact lens case clean and replace every 3-6 months.
Remove the lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.
In addition, regardless of which cleaning/disinfecting solution used, wearers may want to consider performing a "rub and rinse" lens cleaning method, rather than a no rub method, in order to minimize the number of germs and reduce the chances of infection.

Of the 30 patient cases fully investigated so far, 28 wore soft contact lenses and two reported no contact lens use. Twenty-six of the soft contact lens users who remembered which solution they used during the month prior to the infection onset reported using a Bausch & Lomb ReNu brand contact lens solution or a generic brand manufactured by the same company. Five case-patients reported using other solutions in addition to the ReNu brand, and 9 patients reported wearing contact lenses overnight, a known risk factor for microbial keratitis.

"It is important to note that some of the affected patients had used other solutions in addition to the ReNu brand, and that the source of this fungus has not yet been identified. But we're working with CDC and Bausch & Lomb -- and we're investigating other possible causes -- to prevent these infections," Dr. Schultz added.

Bausch and Lomb has informed FDA that they are voluntarily stopping shipment of the ReNu Moisture Loc product while they are continuing to investigate the cause of these infections. Soft contact lens users who have existing supplies of the Renu Moisture Loc should use the product with caution and report any signs and symptoms of eye infection to their doctors.

Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in November 2005. In February 2006, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong after multiple reports of the infection among contact lens users there. No other jurisdictions have taken similar action to date.

Fusarium species are normally found in many plants, soil, and tap water. The annual risk of contact lens-related microbial keratitis is estimated in most studies to be between four and 21 per 10,000 patients, depending on whether the lenses are worn only during the day or continuously overnight.

Fungal keratitis can be associated with trauma to the surface of the eye, immunodeficiencies, and contact lens use. Organisms associated with contact lens-related keratitis are usually bacteria rather than fungus, often arising from contamination of lens care products or from contact lens storage cases.

This is to inform you of a recent increase in the number of reports in the United States of a rare but serious fungal infection of the eye in soft contact lens wearers. The infection, a fungal keratitis caused by the Fusarium fungus, may cause vision loss requiring corneal transplants.

Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are investigating this situation. At this time, Bausch and Lomb has agreed to stop shipping the ReNu MoistureLoc brand contact lens solution. This Notification will be updated as more information becomes available.

Current Testing

In an MMWR Dispatch dated April 10, 2006, CDC stated that it received reports of 109 cases of suspected fungal keratitis in 17 different states. Although the majority of case patients have yet to be interviewed, complete data are available for 30 of them. Twenty-eight of the 30 wore soft contact lenses. Preliminary information obtained by CDC from patient interviews indicates that 26 of these patients remembered which products they used, and that all 26 reported using a Bausch & Lomb ReNu brand contact lens solution in the month prior to the onset of infection. Patients reported using a variety of different ReNu types from multiple different product lots. Five of the patients reported using other solutions in addition to the ReNu product. Nine of the patients reported wearing lenses overnight, a known risk factor for microbial keratitis. Eight required corneal transplantation. Strain typing of the organism is ongoing.

CDC and FDA are investigating these case reports. Also, investigations by CDC, state and local health departments, FDA, and manufacturers of contact lens solutions are underway to define specific behaviors or products that place contact lens wearers at increased risk for Fusarium keratitis.

Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in February 2006. At that time, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong, pending their investigations, after multiple reports of Fusarium keratitis among contact lens users there.

Background on Microbial Keratitis

Microbial keratitis is a severe infection of the cornea. Risk factors for infection include trauma (generally with plant material), chronic ocular surface diseases,

immunodeficiency, and rarely, contact lens use. There are an estimated 30 million soft contact lens users in the United States; the annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users, depending on overnight lens use. Fungal keratitis is a condition more prevalent in warm climates; in the southernmost United States, fungal keratitis comprises up to 35% of microbial keratitis cases compared with 1% in New York. The proportion of fungal keratitis due to Fusarium spp. also varies by region, from 25-62%.

Recommendations

For healthcare providers:

If a patient presents with a microbial keratitis, consider that a fungal infection may be involved and obtain a specimen for laboratory analysis.
Refer patients to an ophthalmologist for immediate treatment.
Report cases of fungal keratitis in contact lens wearers to FDA as noted below.
For contact lens wearers:

Wash hands with soap and water, and dry (lint-free method) before handling lenses.
Wear and replace lenses according to the schedule prescribed by the doctor.
Follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer.
Keep the contact lens case clean and replace every 3-6 months.
Remove the lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.
In addition, regardless of which cleaning/disinfecting solution used, wearers may want to consider performing a ?rub and rinse? lens cleaning method, rather than a no rub method, in order to minimize the number of germs and reduce the chances of infection.

FDA and CDC are very interested in gathering information related to fungal keratitis in contact lens users. We encourage you to report these infections to FDA. FDA will be sharing reported information with CDC. You can report directly to MedWatch, the FDA?s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.

Please include the following information (if available) on the MedWatch reporting form:

Contact lens solutions trade names and lot numbers.
Contact lens type, trade name and mode of wear (extended or daily wear).
Patient non-compliance with contact lens regimen (e.g., overnight wear in daily wear lenses, not cleaning lenses).
Results of all cultures taken (e.g., corneal, conjunctival, contact lens, care solutions, lens case).
Special patient characteristics, including whether the patient was immunocompromised (e.g., used topical or systemic corticosteroids or had diabetes), or had any ocular trauma, surgery, or chronic eye problem.
Topical ocular medications used to treat the patient (including trade names and lot number if available).
Getting More Information

If you have questions about this notification, please contact Nancy Pressly, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 301-594-2968, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 301-594-0650 and we will return your call as soon as possible.

We have learned of a rare but serious eye infection in people who wear soft contact lenses. The infection is fungal keratitis, caused by the Fusarium fungus. It can cause a permanent loss of vision. Several patients with this infection have needed corneal transplants to save their vision.

Beginning in March 2006, the Centers for Disease Control and Prevention (CDC) has so far received 109 reports of suspected fungal infections in the U.S. CDC, FDA, and state and local health departments have been exchanging information regularly and are actively investigating these reports.

One focus of the investigations is to see if either certain behaviors or specific contact lens products increase the risk of infection.

Recommendations

If you wear contact lenses, you should always:

Wash your hands with soap and water and dry them before handling lenses.
Wear and replace your lenses according to the schedule prescribed by your doctor.
Follow instructions from your doctor and your solution manufacturer for cleaning and storing your lenses.
Keep your contact lens case clean and replace every 3-6 months.
Remove the lenses and consult your doctor immediately if your eyes become red, irritated, or your vision changes.
In addition, regardless of which cleaning/disinfecting solution used, you may want to consider performing a ?rub and rinse? lens cleaning method, rather than a no rub method, in order to minimize the number of germs and reduce the chances of infection.

Your eye doctor has been notified of this problem with soft contact lenses. If you have any concerns about your contact lenses, you should contact your doctor. You may also contact FDA?s Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041. For consumer information, select # 2, or to speak with a Medical Device Specialist, select # 4.

FDA will continue to monitor reports of infection. We will update this notice as more information becomes available.

_________________Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato

why isnt the cdc investigating lasik? more people lose their vision from lasik than any fungal infection. 100 people and the cdc goes wild. tens of thousands have lasik complication and the cdc does nothing.

From the above link:
"All 109 infection cases occurred between June 15, 2005, and March 18, and there may be many more. Eight victims required corneal transplants to avert blindness."

LasikTragedy wrote:

why isnt the cdc investigating lasik? more people lose their vision from lasik than any fungal infection. 100 people and the cdc goes wild. tens of thousands have lasik complication and the cdc does nothing.

Excellent point, LasikTragedy. I found the following quote in an article in the March, 2006 Journal of Refractive Surgery.

"Laser in situ keratomileusis (LASIK) is the most
common refractive surgery procedure performed
for the correction of myopia and astigmatism
in the United States. Infection after LASIK surgery is
uncommon, with a reported incidence of 1 in 2919
cases."

At an estimated 1,000,000 LASIK surgeries per year in the United States,
that means 342 sight-threatening eye infections per year from an unnecessary surgical procedure. And it's 3 times that rate for PRK.

Laser in situ keratomileusis (LASIK) is an effective option and currently one of the most commonly applied surgical techniques in the correction of refractive errors such as myopia, hyperopia, and astigmatism. In contrast to photorefractive keratectomy, it maintains the integrity of Bowman's membrane and the epithelium leading to faster visual rehabilitation as well as less pain and discomfort. Nevertheless, following LASIK the stroma is exposed to infectious organisms. Sight-threatening complications after LASIK are reported to be as rare as 1 in 1000 procedures. However, any infectious keratitis remains potentially devastating. Reports about infectious keratitis following LASIK have increasingly surfaced in recent years. We present a review of the literature on microbial keratitis and present our own cases and recommendations for possible prophylaxis and therapy.

_________________Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato

"This is to alert the CDC that infections from LASIK eye surgery are reported to be 1 in 2,919 according to peer-reviewed medical literature. Infectious keratitis is a serious sight-threatening condition caused by an unnecessary surgical procedure. At an estimated 1,000,000 LASIK surgeries per year in the United States, 342 patients are experiencing a sight-threatening eye infection each year. In comparison, the Bausch & Lomb contact lens solution ReNu was linked to 109 cases of eye infections in contact lens wearers from June, 2005 to March, 2006. Please contact me if you need additional information at ..."

_________________Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato

ROCHESTER, N.Y. (AP) -- Bausch & Lomb Inc. made a big blunder when federal regulators revealed in April they were investigating links between its new-formula contact lens cleaner and a rare fungal infection known to cause blindness: It waited three days before withdrawing ReNu with MoistureLoc from the U.S. market.

"If there was something we could go back and change, that would be it," company spokeswoman Meg Graham said. "There isn't a handbook you can go to that tells you exactly what to do here."

Five weeks later, the eye-care product maker's campaign to shore up the reputation of its battered lens care business is under way -- MoistureLoc was permanently recalled Monday from markets around the world. But management and financial analysts wonder if it acted too defensively for too long to deflect lasting damage.

"It's a terrible mistake for a company in crisis not to respond in a timely way," said Howard Rubenstein of Rubenstein Associates, a public relations agency in New York whose crisis-management clients have included Christie's International PLC and Cooper Tire & Rubber Co.

"Americans and the world have short memories about stuff like this -- provided it isn't mishandled," echoed Hayes Roth, chief marketing officer for Landor Associates, a brand consulting firm based in San Francisco. "If they don't protect the credibility of the Bausch & Lomb brand overall so that it is unassailable -- as Tylenol became unassailable -- they will never recover."

Johnson & Johnson's aggressive and very open response to a fatal 1982 tampering scare in Chicago -- it promptly pulled 22 million bottles of Tylenol pain-reliever tablets from stores nationwide and introduced tamperproof packaging -- is considered a classic case study in how best to handle a product-liability crisis.

Bausch & Lomb's ordeal, while less horrifying, sent ripples of anxiety and confusion through the nation's 30 million lens wearers that were magnified by its hesitation in removing MoistureLoc from store shelves.

OK I need to put my 2 cents in. I live in Rochester and have a friend who is one of the people who has been testing thousands of bottles of lens solution for this fungus. There is no evidence at all that B&L is responsible for this and yet everyone (not you guys, but the media, gov etc) is ready to hang them without a trial. I agree that it is crazy how proven causes like PRK and Lasek are ignored and yet this is all over the world news. It really ticks me off.

OK I need to put my 2 cents in. I live in Rochester and have a friend who is one of the people who has been testing thousands of bottles of lens solution for this fungus. There is no evidence at all that B&L is responsible for this and yet everyone (not you guys, but the media, gov etc) is ready to hang them without a trial. I agree that it is crazy how proven causes like PRK and Lasek are ignored and yet this is all over the world news. It really ticks me off.

Obviously, you haven't read the news lately!!!!! Bausch has found a link between the solution and the fungus. So now for all of those people who say it was our fault for not properly cleaning our lenses can kiss my you know what! It's disgusting to even hear the Opthamologists criticizing on how it is our fault and that we over use our contacts. Please!!!! WHat the hell is the point of having Optix 2 if you can't wear them over night. Fact is Bausch and Lomb are FULLY responsible!! There should be no trial it's basically a clean cut case. They provided a solution that was dangerous and now the VICTIMS need to be compensated including myself. They better hurry and jump on the opportunity to settle because it is rather embaressing that some law firms are willing to settle for $75,000 per claimant. To me eyesight is precious and no amount of money especially $75,000 can reverse what we have suffered already.

When medicine and the potential for huge profits are at crossed purposes, it seems like the profit incentive always wins.

Citizens will have to take a more active role to spread the word about harmful procedures and bad doctors. As long as there is big money involved, we can't trust the goverernment or the medical commmunity to do the right thing.

Researchers at the Centers for Disease Control and Prevention have conclusively linked the recent outbreak of Fusarium keratitis to Bausch & Lomb's ReNu with MoistureLoc contact lens solution. A report on their findings was published today in the Journal of the American Medical Association.

[snip]

The MoistureLoc formulation met biocidal standards against Fusarium, the researchers said. However, it contained two chemicals that may have contributed to the fungal outbreak ? alexidine, a disinfectant, and polyquarterium 10, a polysaccharide that helps retain moisture. The persistence of Fusarium activity is not routinely tested in a simulated environment of noncompliant use, the study said. Additionally, the effect of the polysaccharide and surfactant on the growth or survival of Fusarium is not well understood, according to the study.

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